[PDF] Spikevax INN-COVID-19 mRNA Vaccine (nucleoside modified)

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1

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

2 This medicinal product is subject to additional monitoring. This will allow quick identification of

new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

See section 4.8 for how to report adverse reactions.

1. NAME OF THE MEDICINAL PRODUCT

Spikevax 0.2 mg/mL dispersion for injection

Spikevax 0.1 mg/mL dispersion for injection

Spikevax 50 micrograms dispersion for injection in pre-filled syringe

COVID-19 mRNA Vaccine (nucleoside modified)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Table 1. Qualitative and quantitative composition by strength and type of container

Strength Container Dose(s) Composition

Spikevax

0.2 mg/mL

dispersion for injection

Multidose vial

(red flip-off cap)

Maximum 10 doses

of 0.5 mL each

One dose (0.5 mL) contains

100 micrograms of elasomeran, a

COVID-19 mRNA Vaccine

(embedded in lipid nanoparticles).

Maximum 20 doses

of 0.25 mL each

One dose (0.25 mL) contains

50 micrograms of elasomeran, a

COVID-19 mRNA Vaccine

(embedded in lipid nanoparticles).

Spikevax

0.1 mg/mL

dispersion for injection

Multidose vial

(blue flip-off cap)

5 doses

of 0.5 mL each

One dose (0.5 mL) contains

50 micrograms of elasomeran, a

COVID-19 mRNA Vaccine

(embedded in lipid nanoparticles).

Multidose vial

(blue flip-off cap)

Maximum 10 doses

of 0.25 mL each

One dose (0.25 mL) contains

25 micrograms of elasomeran, a

COVID-19 mRNA Vaccine

(embedded in lipid nanoparticles).

Spikevax

50 micrograms

dispersion for injection in pre-filled syringe

Pre-filled syringe

1 dose of 0.5 mL

For single-use only.

Do not use the

pre-filled syringe to deliver a partial volume of 0.25 mL.

One dose (0.5 mL) contains

50 micrograms of elasomeran, a

COVID-19 mRNA Vaccine

(embedded in lipid nanoparticles). Elasomeran is a single--capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of

SARS-CoV-2 (Original).

For the full list of excipients, see section 6.1.

3

3. PHARMACEUTICAL FORM

Dispersion for injection

White to off white dispersion (pH: 7.0 8.0).

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Spikevax is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.

4.2 Posology and method of administration

Posology

Refer to Table 2 for dosing across Spikevax strengths and vaccination type. Table 2. Spikevax posology for primary series, a third dose in severely immunocompromised and booster doses

Strength Vaccination

type

Age(s)

Dose Recommendations

Spikevax

0.2 mg/mL

dispersion for injection

Primary series

Individuals

12 years of

age and older

2 (two) doses

(0.5 mL each, containing

100 micrograms

mRNA)

It is recommended

to administer the second dose

28 days after the

first dose (see sections 4.4 and 5.1).

Children

6 years

through

11 years of

age

2 (two) doses

(0.25 mL each, containing

50 micrograms

mRNA, which is half of the primary dose for individuals

12 years and

older)

Third dose in

severely immuno- compromised

Individuals

12 years of

age and older

1 (one) dose of

0.5 mL,

containing

100 micrograms

mRNA

A third dose may

be given at least

28 days after the

second dose (see section 4.4).

Children

6 years

through

11 years of

age

1 (one) dose of

0.25 mL,

containing

50 micrograms

mRNA 4

Strength Vaccination

type

Age(s)

Dose Recommendations

Booster dose

Individuals

12 years of

age and older

1 (one) dose of

0.25 mL,

containing

50 micrograms

mRNA

Spikevax may be

used to boost individuals

12 years of age and

older who have received a primary series with

Spikevax or a

primary series comprised of another mRNA vaccine or adenoviral vector vaccine at least

3 months after

completion of the primary series (see section 5.1).

Spikevax

0.1 mg/mL

dispersion for injection and Spikevax

50 micrograms

dispersion for injection in pre-filled syringe*

Primary

series

Children

6 years

through

11 years of

age

2 (two) doses

(0.5 mL each, containing

50 micrograms

mRNA each)

It is recommended

to administer the second dose

28 days after the

first dose (see sections 4.4 and 5.1).

Children

6 months

through

5 years of

age

2 (two) doses

(0.25 mL each, containing

25 micrograms

mRNA each, which is half of the primary dose for children 6 years through 11 years of age)*

Third dose in

severely immuno- compromised

Children

6 years

through

11 years of

age

1 (one) dose of

0.5 mL,

containing

50 micrograms

mRNA

A third dose may

be given at least

28 days after the

second dose (see sections 4.4 and 5.1).

Children

6 months

through

5 years of

age

1 (one) dose of

0.25 mL,

containing

25 micrograms

mRNA*

Booster dose

Individuals

12 years of

age and older

1 (one) dose of

0.5 mL,

containing

50 micrograms

mRNA

Spikevax may be

used to boost individuals

12 years of age and

older who have 5

Strength Vaccination

type

Age(s)

Dose Recommendations

Children

6 years

through

11 years of

age

1 (one) dose

(0.25 mL each, containing

25 micrograms

mRNA)* received a primary series with

Spikevax or a

primary series comprised of another mRNA vaccine or adenoviral vector vaccine at least

3 months after

completion of the primary series (see section 5.1). * Do not use the pre-filled syringe to deliver a partial volume of 0.25 mL. For primary series for individuals 12 years of age and older, the 0.2 mg/mL strength vial should be used. For the third dose in severely immunocompromised patients 12 years of age and older, the

0.2 mg/mL strength vial should be used.

Paediatric population

The safety and efficacy of Spikevax in children less than 6 months of age have not yet been established. No data are available.

Elderly

No dose adjustment is required in elderly years of age.

Method of administration

The vaccine should be administered intramuscularly. The preferred site is the deltoid muscle of the upper arm or in infants and young children, the anterolateral aspect of the thigh. Do not administer this vaccine intravascularly, subcutaneously or intradermally. The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products. For precautions to be taken before administering the vaccine, see section 4.4. For instructions regarding thawing, handling and disposal of the vaccine, see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 6

Hypersensitivity and anaphylaxis

Anaphylaxis has been reported in individuals who have received Spikevax. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. Subsequent doses of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of

Spikevax.

Myocarditis and pericarditis

There is an increased risk for myocarditis and pericarditis following vaccination with Spikevax. These conditions can develop within just a few days after vaccination, and have primarily occurred within 14 days. They have been observed more often after the second dose compared to the first dose,

and more often in younger males (see section 4.8). The risk profile appears to be similar for the second

and the third dose. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees should be instructed to seek immediate medical attention if they develop symptoms

indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath,

or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition.

Anxiety-related reactions

Anxiety-ဨ

reactions may occur in association with vaccination as a psychogenic response to the needle injection.

It is important that precautions are in place to avoid injury from fainting.

Concurrent illness

Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.

Thrombocytopenia and coagulation disorders

As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.

Capillary leak syndrome flare-ups

A few cases of capillary leak syndrome (CLS) flare-ups have been reported in the first days after vaccination with Spikevax. Healthcare professionals should be aware of signs and symptoms of CLS

to promptly recognise and treat the condition. In individuals with a medical history of CLS, planning

of vaccination should be made in collaboration with appropriate medical experts. 7

Immunocompromised individuals

The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of Spikevax may be lower in immunocompromised individuals. The recommendation to consider a third dose in severely immunocompromised individuals (see section 4.2) is based on limited serological evidence with patients who are immunocompromised after solid organ transplantation.

Duration of protection

The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical studies.

Limitations of vaccine effectiveness

Individuals may not be fully protected until 14 days after their second dose. As with all vaccines, vaccination with Spikevax may not protect all vaccine recipients.

Excipients with known effect

Sodium

4.5 Interaction with other medicinal products and other forms of interaction

High-dose quadrivalent influenza vaccine can be concomitantly administered with Spikevax.

4.6 Fertility, pregnancy and lactation

Pregnancy

A large amount of observational data from pregnant women vaccinated with Spikevax during the second and third trimester has not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no

increased risk for miscarriage has been seen. Animal studies do not indicate direct or indirect harmful

effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Spikevax can be used during pregnancy.

Breast-feeding

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to Spikevax is negligible. Observational data from women who were breastfeeding after vaccination have not shown a risk for adverse effects in breastfed newborns/infants. Spikevax can be used during breastfeeding.

Fertility

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity

(see section 5.3).

4.7 Effects on ability to drive and use machines

Spikevax has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines. 8

4.8 Undesirable effects

Summary of the safety profile

Adults

The safety of Spikevax was evaluated in an ongoing Phase 3 randomised, placebo-controlled,

observer-blind clinical study conducted in the United States involving 30 351 participants 18 years of

age and older who received at least one dose of Spikevax (n=15 185) or placebo (n=15 166) (NCT04470427). At the time of vaccination, the mean age of the population was 52 years (range

18-95); 22 831 (75.2%) of participants were 18 to 64 years of age and 7 520 (24.8%) of participants

were 65 years of age and older. The most frequently reported adverse reactions were pain at the injection site (92%), fatigue (70%), headache (64.7%), myalgia (61.5%), arthralgia (46.4%), chills (45.4%), nausea/vomiting (23%), axillary swelling/tenderness (19.8%), fever (15.5%), injection site swelling (14.7%) and redness (10%). Adverse reactions were usually mild or moderate in intensity and resolved within a few days

after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.

Overall, there was a higher incidence of some adverse reactions in younger age groups: the incidence of axillary swelling/tenderness, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting and fever was higher in adults aged 18 to < 65 years than in those aged 65 years and above. Local and systemic adverse reactions were more frequently reported after Dose 2 than after Dose 1.

Adolescents 12 through 17 years of age

Safety data for Spikevax in adolescents were collected in an ongoing Phase 2/3 randomised,

placebo-controlled, observer-blind clinical study with multiple parts conducted in the United States.

The first portion of the study involved 3 726 participants 12 through 17 years of age who received at

least one dose of Spikevax (n=2 486) or placebo (n=1 240) (NCT04649151). Demographic characteristics were similar among participants who received Spikevax and those who received placebo. The most frequent adverse reactions in adolescents 12 to 17 years of age were injection site pain (97%), headache (78%), fatigue (75%), myalgia (54%), chills (49%), axillary swelling/tenderness

(35%), arthralgia (35%), nausea/vomiting (29%), injection site swelling (28%), injection site erythema

(26%), and fever (14%).

This study transitioned to an open-label Phase 2/3 study in which 1 346 participants 12 years through

17 years of age received a booster dose of Spikevax at least 5 months after the second dose of the

primary series. No additional adverse reactions were identified in the open-label portion of the study.

Children 6 years through 11 years of age

Safety data for Spikevax in children were collected in an ongoing Phase 2/3 two-part randomised, observer-blind clinical study conducted in the United States and Canada (NCT04796896). Part 1 is an open-label phase of the study for safety, dose selection, and immunogenicity and included

380 participants 6 years through 11 years of age who received at least 1 dose (0.25 mL) of Spikevax.

Part 2 is the placebo-controlled phase for safety and included 4 016 participants 6 years through

11 years of age who received at least one dose (0.25 mL) of Spikevax (n=3 012) or placebo (n=1 004).

No participants in Part 1 participated in Part 2. Demographic characteristics were similar amongquotesdbs_dbs8.pdfusesText_14

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